Opinion for the Court filed by Circuit Judge Spottswood W. ROBINSON.
SPOTTSWOOD W. ROBINSON, III, Circuit Judge:
Carita Richardson and her parents brought an action in the District Court alleging that her congential limb defects resulted from ingestion of Bendectin by her mother, Etheleen, during her pregnancy. At the time, Bendectin, an anti-nausient drug, was manufactured by Richardson-Merrell, Inc., which since has been succeeded by Merrell-Dow Pharmaceuticals, Inc. Following a lengthy trial, the jury returned a verdict awarding damages in the sums of $1 million to Carita and $160,000 to the parents. On Merrell's motion, the District Court granted judgment n.o.v. in its favor, and the propriety of doing so is the single question on this appeal. After careful consideration of the record, we agree that the evidence was so one-sided as to warrant fully the court's action. Accordingly, we affirm.
I. THE BACKGROUND
The Bendectin taken by Mrs. Richardson was a combination of pyridoxine hydrochloride (vitamin B-6), doxylamine succinate (an antihistamine), and dicyclomine hydrochloride (an antispasmodic).
Early in her pregnancy,
A. The Procedural History
Carita and her parents filed suit in the District Court for the District of Columbia. Along with over 1,500 other Bendectin lawsuits, the case was transferred for pretrial proceedings, pursuant to an order of the Judicial Panel on Multidistrict Litigation, to the Southern District of Ohio,
At trial, to avoid a compromise verdict, the District Court submitted the case to the jury in two stages, first on the issue of causation and then on issues of failure to warn and damages. The jury found that Bendectin was a human teratogen, a substance capable of causing birth defects, when taken in recommended doses by a pregnant woman during the period of organogenesis of a unborn child and that Bendectin was the proximate cause of Carita's birth defects. The jury also found a lack of proper warning of the dangers associated with the drug, and accordingly, returned its $1.16 million verdict for the Richardsons.
Merrell moved for judgment n.o.v. or, in the alternative, for a new trial. The court granted the motion for judgment n.o.v., holding that on the basis of the evidence presented no reasonable jury could find that Carita's birth defects were more likely than not caused by Bendectin.
The Richardsons argue that the District Court erred in both respects because there was sufficient credible evidence to support the verdict in their favor.
B. The District Court's Opinion
In granting judgment n.o.v., the District Court stated:
The court summarized the evidence, focusing on the testimony of Dr. Alan K. Done, the Richardson's principal witness on causation. On the basis of (1) Bendectin's chemical structure, (2) in vitro (test tube) studies, (3) in vivo (animal) teratology studies conducted by Merrill and others, and (4) the "human data" he had reviewed — epidemiological studies which he found "defective, inconclusive, or both"
Despite this opinion, the court held that there was no "battle of experts" in this case, a circumstance which, if true, would have required that the verdict remain standing.
The District Court also examined closely the testimony of Dr. Raymond Seltser, an expert witness for the defense, who testified about the significance of the scientific literature on Bendectin. Dr. Seltser's review of the literature uncovered fourteen cohort studies and seven case control studies, "in none of which is there to be found a statistically significant increase in the relative risk of any congential limb malformations associated with Bendectin exposure."
The District Court observed that Dr. Done had neither performed his own studies nor published his criticisms of the studies performed by others, but nonetheless testified in contradiction to "not only Dr. Seltser but to the findings of all those researchers who have studied and published in the twenty-odd years since the investigation of Bendectin began."
The District Court also noted that Dr. Seltser's judgment regarding the current state of knowledge about Bendectin within the scientific community was corroborated by FDA's Fertility and Maternal Health Drugs Advisory Committee, which was convened in 1980 to evaluate the evidence on
The District Court concluded that in light of Bendectin research and the published literature, Dr. Done's opinion was beyond the range of acceptability. The court's summary of its analysis is succinct:
As a result, the court granted Merrell's motion for judgment n.o.v.
II. STANDARD OF REVIEW
The standard for awarding judgment n.o.v. is the same as that governing rulings on motions for directed verdicts.
The Court, citing long-established precedent, pointed out that a judge is not required to submit a case to the jury "`merely because some evidence has been introduced by the party having the burden of proof, unless the evidence be of such a character that it would warrant the jury in finding a verdict in favor of that party.'"
III. THE EVIDENCE
The question whether Bendectin causes limb reduction defects is scientific in nature, and it is to the scientific community that the law must look for the answer. For this reason, expert witnesses are indispensable in a case such as this. But that is not to say that the court's hands are inexorably tied, or that it must accept uncritically any sort of opinion espoused by an expert merely because his credentials render him qualified to testify. The District Court ruled that Dr. Done's opinion lacked "a genuine basis, `in or out of the record,'" and that his "theoretical speculations" could not sustain the Richardsons' burden of proving causation.
Federal Rule of Evidence 703 lays the foundation for our consideration of what constitutes adequate expert testimony.
As we have heretofore stated, Rule 703 "was intended to broaden the acceptable bases of expert opinion, but it was not intended ... to make summary judgment impossible whenever a party has produced an expert to support its position;"
We must therefore look behind Dr. Done's ultimate conclusion that Bendectin causes birth defects and analyze the adequacy of its foundation. Dr. Done predicated his opinion upon four different factors: (1) chemical structure activity analysis, (2) in vitro (test tube) studies, (3) in vivo (animal) teratology studies, and (4) epidemiological studies.
In speaking of chemical structure activity analysis, Dr. Done referred to the concept that drugs with similar chemical structures may be expected to have similar properties and produce analogous effects.
Dr. Done also acknowledged that in vivo (animal) teratology studies are similarly of but scant utility in drawing conclusions about whether a substance will cause birth defects in humans. "The fact that [a substance does so] in an animal," he conceded, "doesn't necessarily mean it will in humans, but it does mean, again, that it is likely enough to do so in humans that you have to accept the notion that it will do that unless you prove otherwise. It just increases the need to prove otherwise."
The in vitro (test tube) experiments relied on by Dr. Done studied the effects of Bendectin components upon frog nerve fibers and the mesenchyme cells of mouse limb buds for evidence that similar or other defects might occur in humans. Again, the value of such an examination as a predictor of human teratogenicity is extremely meager, and once again we find ourselves in the realm of suspicion. Positive results from in vitro studies may provide a clue signaling the need for further research, but alone do not provide a satisfactory basis for opining about causation in the human context.
These three types of studies then — chemical, in vitro, and in vivo — cannot furnish a sufficient foundation for a conclusion that Bendectin caused the birth defects at issue in this case. Studies of this kind, singly or in combination, are not capable of proving causation in human beings in the face of the overwhelming body of contradictory epidemiological evidence. Perhaps mindful of this, the last type of evidence considered by Dr. Done consisted of the epidemiological studies. When such studies are available and relevant, and particularly when they are numerous and span a significant period of time, they assume a very important role in determinations of questions of causation. Dr. Done himself conceded the import of this literature when he agreed on cross-examination that "in connection with the animal studies ... because so many substances are teratogenic in animals, before you can make a conclusion that a substance is teratogenic in humans, you must look to the human data."
Dr. Done further admitted that no one who has published work on Bendectin has concluded that there is a statistically significant association between Bendectin and limb reduction defects of the type at issue in this case.
Since the Richardsons had the burden of proving that Bendectin causes birth defects, the law cannot tolerate a presumption of teratogenicity. That may be prudent in the medical community at the early stages of research where caution is vital and suspicion comes naturally, but it obviously is not acceptable when teratogenicity becomes an issue in a judicial tribunal.
The First Circuit expressed similar concerns in Lynch v. Merrell-National Laboratories Division of Richardson-Merrell, Inc.,
The Richardsons, however, direct attention to our decision in Ferebee v. Chevron Chemical Co.,
We noted the possibility that the case may have been the first of its type, or that the plaintiff's doctors may have been the first alert enough to recognize a causal connection between paraquat and pulmonary fibrosis.
The case before us, however, is not like Ferebee. Indeed, we are at the other end of the spectrum, a great distance from the "frontier of current medical and epidemiological inquiry." And far from a paucity of scientific information on the oft-asserted claim of causal relationship of Bendectin and birth defects, the drug has been extensively studied and a wealth of published epidemiological data has been amassed, none of which has concluded that the drug is teratogenic. Uniquely to this case, the law now has the benefit of twenty years of scientific study, and the published results must be given their just due.
The circumstances of the case are tragic and Carita Richardson's plight evokes the utmost sympathy. It would be foolhardy to expect members of the jury to be without compassion for the catastrophe that befell this family. That is a natural response of the human spirit, and is without legal consequence so long as it is properly controlled. But in a case such as this it not only is appropriate but indeed imperative that the court remain vigilant to ensure that neither emotion nor confusion has supplanted reason.
We arrive at our conclusions in this case fully cognizant of and particularly sensitive to the importance of the jury's role in our legal scheme. As in Stacey v. Allied Stores,
In Stacey, however, this court "discern[ed] no principled basis for concluding that [the] verdict was infected by prejudice or premised upon surmise, conjecture, or a mere scintilla of evidence."
It is important to also stress that the District Court's grant of judgment n.o.v. in this case did not usurp the jury's function. Whether an expert's opinion has an adequate basis, and whether without it an evidentiary burden has been carried, are issues of law falling within the province of the court. "[T]he law in its wisdom," we have observed, "has invested trial judges with the power to correct juries who base their verdicts on considerations not embodied in the evidence."
The judgment appealed from is accordingly Affirmed.
In taking account of that decision, the District Court in this case concluded that although the Oxendine court summarized accurately the testimony presented, it "did not address the significance of certain evidence bearing upon the current state of scientific knowledge" — evidence elaborately presented in the case at bar. It was the District Court's view that the Court of Appeals in Oxendine had "judicially reopened an esoteric 20-year-old controversy which is by now essentially settled within the scientific community." Richardson, supra note 6, 649 F.Supp. at 799.
Subsequent to oral argument in the case at bar, the defendant in Oxendine moved for relief from the judgment, and retrial of the case was ordered. Oxendine v. Merrell Dow Pharmaceuticals, Inc., Civ. No. 1245-82 (Super.Ct.D.C. Feb. 12, 1988) (memorandum order). An appeal from that ruling is now pending before the Court of Appeals, leaving unsettled the ultimate outcome in Oxendine and the decisional foundation thereof. But whatever the fate of Oxendine may be, the Richardsons' Erie challenge must be rejected. We note that the Richardsons' argument ignores the differences in the evidence presented in the two cases. Moreover, the Erie doctrine applies to state substantive, not procedural, law to be followed by federal courts exercising diversity jurisdiction. See, e.g., Guaranty Trust Co. v. York, 326 U.S. 99, 65 S.Ct. 1464, 89 L.Ed. 2079 (1945). In addition, it is clear that Erie does not affect the federal courts' application of the Federal Rules of Evidence. Eli Lilly & Co. v. Home Ins. Co., 254 U.S.App.D.C. 1, 6, 794 F.2d 710, 715 (1986); see also C. Wright, A. Miller & E. Cooper, Federal Practice and Procedure § 4512 (1982). Because the admissibility of testimony, which is governed by the Federal Rules of Evidence, is the crux of our decision in this case, see infra notes 37-42 and accompanying text, the Richardsons' argument must be rejected.
Appellants also challenge the District Court's alternative grant of a new trial. Our disposition, however, makes it unnecessary for us to reach this issue.